510(k) K905286

IFSA STERILE NLYLON MONOFIL NONABSOR SURG SUTURES by Internacional Farmaceutica, S.A. DE C.V. — Product Code GAR

K905286 is an FDA 510(k) premarket notification submitted by Internacional Farmaceutica, S.A. DE C.V. for the device "IFSA STERILE NLYLON MONOFIL NONABSOR SURG SUTURES". The FDA issued a decision of Substantially Equivalent on February 11, 1991. The device falls under product code GAR (Suture, Nonabsorbable, Synthetic, Polyamide), a Class II device regulated under 21 CFR 878.5020. Internacional Farmaceutica, S.A. DE C.V. has at least 9 other 510(k) clearances on record.